Minimally Invasive Fixation for Distal Radius Fractures (DRF)

January 30, 2023 updated by: Abdalraouf M Ghozaly, Assiut University

Minimally Invasive Surgical Fixation for Unstable Fractures of the Distal End Radius in Adults

Minimally invasive surgery avoids the tissue damage and impairment of physiological function caused by open surgery because of its precise location techniques and can effectively promote the early recovery of wrist function. Under conditions of no cutting of fracture fragments, no blood supply compromise in the fracture fragments

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Distal radial fracture is common fracture and internal fixation needed in many cases so we use minimally invasive fixation in this study to minimize open surgery compilations

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. patients with unstable distal radial fracture
  2. skeletally mature Patients.
  3. Acute fractures within one weeks of injury

Exclusion Criteria:

  1. contaminated open fractures.
  2. fractures associated with vascular injury requiring repair, and suspected pathologic Fracture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Minimally invasive fixation
Minimally Invasive Surgical Fixation for Unstable Fractures of the distal end Radius in Adults
Device: Minimal invasive surgical fixation of distal radius Fractures
Fixation of distal radius Fractures by minimal invasive technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fracture healing
Time Frame: 6 minths
Rate of fracture healing
6 minths
Wrist function
Time Frame: One year
Percentage of restoration of wrist function
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fracture compilations
Time Frame: One year
Percentage of fracture healing compilations
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Ab Ma Ghozaly, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 20, 2024

Primary Completion (Anticipated)

September 1, 2025

Study Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (Actual)

January 3, 2022

Study Record Updates

Last Update Posted (Actual)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Minimally invasive fixation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study analytic results

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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